Summary

Eligibility
for people ages 18-85 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

The purpose of this study is to collect long-term safety and tolerability data for CK-3773274

Official Title

An Open-Label Study of CK-3773274 for Patients With Symptomatic Hypertrophic Cardiomyopathy (HCM) and Left Ventricular Outflow Tract Obstruction

Keywords

Obstructive Hypertrophic Cardiomyopathy oHCM CK-3773274 CK-274 Cardiomyopathies Cardiomyopathy, Hypertrophic Hypertrophy

Eligibility

You can join if…

Open to people ages 18-85

  • Completion of a Cytokinetics trial investigating CK-3773274
  • LVEF ≥55% at the Screening Visit

You CAN'T join if...

  • Has taken any investigational study drug other than CK-3773274 within 30 days prior to screening
  • Since completion of a previous trial of CK-3773274 has:
  • Developed new-onset paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) <30 days prior to screening. Patient may re-screen for CY 6022 after 30 days if heart rate (HR) <100 bpm and/or rhythm is stable >30 days
  • Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation)
  • Has current obstructive coronary artery disease (>70% stenosis documented in one or more arteries)
  • Has moderate or severe aortic valve stenosis
  • Had a confirmed LVEF <40% with an associated dose interruption during CY 6021
  • Has been treated with drugs that have negative inotropic activity (except for beta-blockers, calcium channel blockers, or disopyramide) as monotherapy or in combination within 30 days prior to screening. Patients receiving treatment with disopyramide require approval from the medical monitor prior to enrollment.
  • History of syncope or sustained ventricular tachyarrhythmia with exercise within 30 days prior to screening
  • History of appropriate ICD shock within 30 days prior to screening
  • Has received treatment with mavacamten within 3 months prior to screening

Locations

  • UCSF Medical Center accepting new patients
    San Francisco California 94143 United States
  • Oregon Health & Science University accepting new patients
    Portland Oregon 97239 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Cytokinetics
ID
NCT04848506
Phase
Phase 2
Study Type
Interventional
Last Updated